Easily accessible regulators’ assessment reports of pharmaceuticals by National Competent Authority
| National competent authority | Name of report | Content | Redactions | URL |
| Food and Drugs Administration—USA | Approval package with Medical Officer and Statistical Officer Report | Review of the evidence for indication applied for by the manufacturer | Yes | http://www.fda.gov/drugsatfda |
| European Medicines Agency | European Public Assessment Reports | Assessment of the evidence for the indication applied for by the manufacturer | No |
https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_
field/Human/ema_group_types/ema_medicine?search |
| Therapeutic Goods Administration—Australia (TGA) | Australian Public Assessment Reports for prescription medicines | Evaluation of a prescription medicine and the considerations that led TGA to approve or not approve a prescription medicine submission. | Yes- experts’ names |
https:
//www tga.gov.au/australian-public-assessment- reports-prescription-medicines-auspars |
| Health Canada—Canada | Summary Basis of Decision | Brief assessment of evidence supporting indication application with milestones | No |
https:
//hpr-rps.hres.ca/reg-content/summary-basis-decision.php |
| Pharmaceuticals and Medical Devices Agency—Japan | Report on the Deliberation Results (in English and Japanese) | Review of the evidence for the indication applied for by the manufacturer | Yes |
https:
//www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html |